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510(k) Data Aggregation

    K Number
    K971345
    Device Name
    CHOL OR CHOLESTEROL
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-05-29

    (49 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHOL OR CHOLESTEROL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cholesterol Reagent is intended for the quantitative determination of serum total cholesterol using Beckman SYNCHRON CX Systems. The results are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood as well as lipid and lipoprotein metabolism disorders.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to an FDA 510(k) clearance letter for a "Cholesterol Reagent" and does not contain the detailed information required to answer the questions about acceptance criteria and a study proving a device meets them. This document is a regulatory approval letter, not a technical report or clinical study summary.

    Therefore, I cannot provide the requested information from the given input.

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